Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Erhan 2008.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis
Participants Baseline characteristics
Placebo (group 1)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 52.5 ± 13.9

  • Weight (mean ± SD, median (IQR), median (range)): 63.9 ± 11.2

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 70

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): NA/0

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 93

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction

  • Type of surgery: laparoscopic cholecystectomy


Ondansetron (group 2)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 50.3 ± 14.6

  • Weight (mean ± SD, median (IQR), median (range)): 62.1 ± 7.9

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 85

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): NA/0

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 82

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction

  • Type of surgery: laparoscopic cholecystectomy


Granisetron (group 3)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 50.1 ± 13.0

  • Weight (mean ± SD, median (IQR), median (range)): 61.2 ± 5.7

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 85

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): NA/0

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 93

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction

  • Type of surgery: laparoscopic cholecystectomy


Dexamethasone (group 4)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 53.4 ± 7.6

  • Weight (mean ± SD, median (IQR), median (range)): 62.9 ± 5.8

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 65

  • Non‐smoker (%): 100

  • History of PONV/motion sickness (%): NA/0

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 85.8

  • Use of perioperative opioids (if yes, which?): 2 µg/kg fentanyl for induction

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: scheduled for laparoscopic cholecystectomy with general anaesthesia, between 21 and 75 years of age (mean 51.5 years)
Excluded criteria: ASA III or IV; over 75 years of age; body mass index > 30; pregnancy; smoking; signs of gastrointestinal, endocrine, renal, hepatic, or immunological disease; use of opioids or tranquillizers less than 1 week before the operation; treatment with steroids; history of alcohol or drug abuse; history of motion sickness; preoperative diagnosis of gallbladder empyema and previous endoscopic sphincterotomy for common bile duct stones; conversion to open cholecystectomy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness, perioperative opioids): no; (history of PONV): unclear
Interventions Intervention characteristics
Placebo (group 1)
  • Dose: 0.9% NaCl

  • Time point of administration: 15 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV


Ondansetron (group 2)
  • Dose: 4 mg

  • Time point of administration: 15 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV


Granisetron (group 3)
  • Dose: 3 mg

  • Time point of administration: 15 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV


Dexamethasone (group 4)
  • Dose: 8 mg

  • Time point of administration: 15 minutes before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV

Outcomes Vomiting (0 to 24 hours)
  • Outcome type: dichotomous outcome


Vomiting (0 to 6 hours)
  • Outcome type: dichotomous outcome


Vomiting (6 to 12 hours)
  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)
  • Outcome type: dichotomous outcome


Complete response (no PONV) in 24 hours
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: Yamac Erhan
Institution: Department of Surgery, Faculty of Medicine, Celal Bayar University, Manisa 45040, Turkey
Email: yamacerhan@yahoo.com
Address: Department of Anesthesiology, Faculty of Medicine, Ege University, 35100 Izmir, Turkey
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomly divided into four groups"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "study medications were prepared by a technician anesthetist in identical 5 ml syringes and administered in a double‐blind fashion"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the incidence of nausea and vomiting was recorded during three assessment periods, 0–6 h, 6–12 h, and 12–24 h, by nursing staff without knowledge of which antiemetic the patients had received. Both..."
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "all 80 patients enrolled in the study had their surgical procedures completed"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "the mean values for age, weight, height, time of surgery, and time of anesthesia are given in Table 1. Groups were comparable with respect to demographic data, time of surgery, and time of anesthesia"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness, perioperative opioids): no; (history of PONV): unclear